Drugs
Drug Innovation
Innovation drives progress. When it comes to innovating new drugs, FDA's Center for Drug Evaluation and Research (CDER) supports the drug development industry at every step of the process. With its understanding of the science used to create new chemical compounds, testing and manufacturing procedures, and the conditions new products are designed to treat, FDA provides the scientific and regulatory support needed to bring new therapies to the medical community and the American public. An ongoing update of FDA's Center for Drug Evaluation and Research's novel drug approvals of calendar year 2012 The availability of new drugs often means new treatment options for patients, and advances in health care for the American public. For this reason, "innovation" is a key word throughout the pharmaceutical industry and the healthcare community. CDER regulates over-the-counter and brand name and generic prescription drugs. In this function, CDER supports innovation and plays a key role in helping to advance new drug development. Each year CDER typically approves a wide range of new brand name and generic drug products. Many, however, are often duplicate therapies that will compete in the marketplace with the same kind of products already approved. But some are truly new and innovative chemical structures never used before in clinical practice (see list of 2011 NMEs1). Such novel new drugs are often called new molecular entities (NMEs). Many of these products offer new hope for patients.
(The Drug Name link provides full product details, i.e., prescribing information, approval history, and reviews.) |
|
Drug Name | Active Ingredient | Date | What it’s used for |
|---|---|---|---|
| Elelyso | taliglucerase alfa | 5/1/12 | For long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder |
| Stendra | avanafil | 4/27/12 | To treat erectile dysfunction. |
| Amyvid | Florbetapir F 18 | 4/6/12 | Used as a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. |
| Omontys | peginesatide | 3/27/12 | To treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD). Press Release |
| Surfaxin | lucinactant | 3/6/12 | For the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants. Press Release |
| Zioptan | tafluprost | 2/10/12 | For reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Press Release |
| Kalydeco | ivacaftor | 1/31/12 | For the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene. |
| Erivedge | vismodegib | 1/30/12 | To treat adult patients with basal cell carcinoma, the most common type of skin cancer. |
| Inlyta | axitinib | 1/27/12 | To treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. |
| Picato | ingenol mebutate | 1/23/12 | For the topical treatment of actinic keratosis. |
| Voraxaze | glucarpidase | 1/17/12 | To treat patients with toxic levels of methotrexate in their blood due to kidney failure. |
